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Cerliponase Side Effects

The most commonly reported side effects of cerliponase include pyrexia, seizure, and vomiting, based on 499 FDA adverse event reports from 2017 to 2025. 3.4% of reports found the drug to be ineffective.

Cerliponase side effects

Percentages show how often each reaction appears relative to total reports for cerliponase.

1
Pyrexia17.4%87
2
Seizure14.6%73
3
Vomiting7.4%37
4
Device Related Infection5.6%28
5
Device Leakage5.4%27
6
Csf Culture Positive4.8%24
7
Pneumonia4.4%22
8
Headache3.8%19
9
Nausea3.4%17
10
Drug Ineffective3.4%17
11
Off Label Use3.4%17
12
Device Occlusion3.0%15
13
General Physical Health Deterioration2.8%14
14
Dystonia2.8%14
15
Irritability2.6%13

These are voluntary reports and do not establish that cerliponase caused these reactions.

Report severity

72.3%Serious361 reports
37.1%Hospitalizations185 reports
4.6%Fatal23 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cerliponase drug interactions

Other drugs that appear in adverse event reports alongside cerliponase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Clobazam1.0%5
2
Levetiracetam0.6%3
3
Lamotrigine0.6%3
4
Risperidone0.6%3
5
Valproate-sodium0.4%2
6
Phenobarbital-sodium0.4%2
7
Topiramate0.4%2
8
Phenytoin0.4%2
9
Diazepam0.2%1
10
Thiopental-sodium0.2%1
11
Clonazepam0.2%1
12
Midazolam0.2%1
13
Zonisamide0.2%1
14
Bevacizumab0.2%1
15
Sacubitril0.2%1

Taken alongside

1
Levetiracetam13.8%69
2
Clobazam7.4%37
3
Acetaminophen5.2%26
4
Valproic-acid5.0%25
5
Clonazepam4.2%21
6
Lamotrigine3.4%17
7
Ondansetron2.8%14
8
Zonisamide2.6%13
9
Diazepam2.6%13
10
Midazolam2.6%13
11
Baclofen2.2%11
12
Diphenhydramine1.8%9
13
Valproate-sodium1.6%8
14
Ibuprofen1.6%8
15
Cetirizine-hydrochloride1.4%7

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports cerliponase side effects

23.4% of cerliponase adverse event reports involve female patients and 28.5% involve male patients. The largest age group is child at 80%. These figures reflect who reports side effects, not underlying risk.

Sex

Female23.4%
Male28.5%
Unknown48.1%

Age group

< 21.4%
2–1180.2%
12–1714.0%
18–644.1%
65+0.5%

What is cerliponase used for

Conditions and purposes for which patients were taking cerliponase when the adverse event was reported.

EpilepsyGait DisturbanceHereditary AtaxiaInfusionMyoclonic EpilepsyNeuronal Ceroid LipofuscinosisNeuronal Ceroid LipofuscinosisProduct Used For Unknown IndicationProduct Used For Unknown IndicationRetinopathy

Cerliponase brand names and reporting trend

Cerliponase is sold under the brand name Brineura.

Brand names

Brineura9

Quarterly reports (20172025)

20182020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking cerliponase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.